NCT02899507

Brief Summary

The purpose of this study is to determine whether there is potential benefits of prophylactic antibiotic treatment in comatose survivors of out-of-hospital cardiac arrest (OHCA) treated in intensive care unit with therapeutic hypothermia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
Last Updated

September 14, 2016

Status Verified

August 1, 2016

Enrollment Period

1.5 years

First QC Date

June 30, 2016

Last Update Submit

September 8, 2016

Conditions

Out-of-hospital Cardiac Arrest

Keywords

Out-of-hospital cardiac arrestProphylactic antibiotics

Outcome Measures

Primary Outcomes (1)

  • Value of C-reactive protein (CRP) at day three

    Expressed in milligram/litre (normal \<5 mg/L)

    Three days after admission to Intensive care unit (ICU)

Secondary Outcomes (10)

  • Severity of systemic inflammatory response estimated by peak white blood cell count (WBC)

    First measurement at admission in hospital and afterwards in 24 hours intervals during stay in the intensive care unite (ICU) but not longer then first seven days

  • Severity of systemic inflammatory response estimated by peak value of procalcitonin (PCT)

    First measurement at admission in hospital and afterwards in 24 hours intervals during stay in the intensive care unite (ICU) but not longer then first seven days

  • Severity of systemic inflammatory response estimated by peak value of neutrophil Cluster of differentiation 64 (CD 64)

    First measurement at admission in hospital and afterwards in 24 hours intervals in the first three days

  • Appearance of pneumonia on chest X ray

    Chest X ray was taken on admission and afterwards on daily basis during the stay in the intensive care unite but not longer than first week

  • Incidence of positive blind mini bronchoalveolar lavage (Mini-BAL) on day 3

    Mini-BAL was performed on the third day after the sudden cardiac arrest

  • +5 more secondary outcomes

Study Arms (2)

Prophylactic antibiotic

EXPERIMENTAL

Amoxicillin-Clavulanic acid 1.2g every 8h

Drug: Amoxicillin-Clavulanic acid

Clinically-driven antibiotics

NO INTERVENTION

Administration of antibiotics in clinically-driven group was at the discretion of attending intensivist. Selection of antibiotic in clinically-driven group was empirical or based on the results of bacterial cultures if already available.

Interventions

Amoxicillin-Clavulanic acidDRUG

Patients without evidence of tracheobronchial aspiration were randomized to immediate prophylactic Amoxicillin-Clavulanic acid 1,2 gr/8h

Also known as: Amoksiklav, Augmentin
Prophylactic antibiotic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female and male over 18 years old
  • Comatose survivors of out-of-hospital cardiac arrest treated in intensive care unit with therapeutic hypothermia

You may not qualify if:

  • Suspected or confirmed pregnancy
  • Allergy to amoxicillin-clavulanic acid
  • Tracheobronchial aspiration
  • Antibiotic therapy before cardiac arrest
  • Need of antibiotics due to other causes
  • Candidates for immediate veno-arterial extracorporeal membrane oxygenation (VA ECMO)
  • Patients in whom no active treatment was decided on admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (8)

  • Tomte O, Andersen GO, Jacobsen D, Draegni T, Auestad B, Sunde K. Strong and weak aspects of an established post-resuscitation treatment protocol-A five-year observational study. Resuscitation. 2011 Sep;82(9):1186-93. doi: 10.1016/j.resuscitation.2011.05.003. Epub 2011 May 14.

    PMID: 21636202BACKGROUND

  • Stub D, Hengel C, Chan W, Jackson D, Sanders K, Dart AM, Hilton A, Pellegrino V, Shaw JA, Duffy SJ, Bernard S, Kaye DM. Usefulness of cooling and coronary catheterization to improve survival in out-of-hospital cardiac arrest. Am J Cardiol. 2011 Feb 15;107(4):522-7. doi: 10.1016/j.amjcard.2010.10.011. Epub 2010 Dec 22.

    PMID: 21184989BACKGROUND

  • Kocjancic ST, Jazbec A, Noc M. Impact of intensified postresuscitation treatment on outcome of comatose survivors of out-of-hospital cardiac arrest according to initial rhythm. Resuscitation. 2014 Oct;85(10):1364-9. doi: 10.1016/j.resuscitation.2014.06.028. Epub 2014 Jul 8.

    PMID: 25010782BACKGROUND

  • Perbet S, Mongardon N, Dumas F, Bruel C, Lemiale V, Mourvillier B, Carli P, Varenne O, Mira JP, Wolff M, Cariou A. Early-onset pneumonia after cardiac arrest: characteristics, risk factors and influence on prognosis. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1048-54. doi: 10.1164/rccm.201102-0331OC.

    PMID: 21816940BACKGROUND

  • Mongardon N, Perbet S, Lemiale V, Dumas F, Poupet H, Charpentier J, Pene F, Chiche JD, Mira JP, Cariou A. Infectious complications in out-of-hospital cardiac arrest patients in the therapeutic hypothermia era. Crit Care Med. 2011 Jun;39(6):1359-64. doi: 10.1097/CCM.0b013e3182120b56.

    PMID: 21336107BACKGROUND

  • Gajic O, Festic E, Afessa B. Infectious complications in survivors of cardiac arrest admitted to the medical intensive care unit. Resuscitation. 2004 Jan;60(1):65-9. doi: 10.1016/j.resuscitation.2003.08.005.

    PMID: 14987786BACKGROUND

  • Woo JH, Lim YS, Yang HJ, Park WB, Cho JS, Kim JJ, Hyun SY, Lee G. Factors associated with pneumonia in post-cardiac arrest patients receiving therapeutic hypothermia. Am J Emerg Med. 2014 Feb;32(2):150-5. doi: 10.1016/j.ajem.2013.10.035. Epub 2013 Oct 26.

    PMID: 24268585BACKGROUND

  • Ribaric SF, Turel M, Knafelj R, Gorjup V, Stanic R, Gradisek P, Cerovic O, Mirkovic T, Noc M. Prophylactic versus clinically-driven antibiotics in comatose survivors of out-of-hospital cardiac arrest-A randomized pilot study. Resuscitation. 2017 Feb;111:103-109. doi: 10.1016/j.resuscitation.2016.11.025. Epub 2016 Dec 14.

    PMID: 27987397DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Marko Noč, MD, PhD

    University Medical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 30, 2016

First Posted

September 14, 2016

Study Start

September 1, 2013

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

September 14, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)